A Pilot Study Investigating the Feasibility of the Saebo Arm Training Program on an Inpatient Population

This study has been completed.
Sponsor:
Collaborator:
Saebo, Inc.
Information provided by:
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00489580
First received: June 20, 2007
Last updated: July 23, 2007
Last verified: July 2007
  Purpose

Study Objectives:

  1. To document the safe and effective application of the F.T.M. Arm Training Program using the SaeboFlex to an inpatient post stroke rehabilitation population.
  2. To compare functional improvements in hand and UE use achieved with the F.T.M. program as compared to generally applied therapeutic treatment approaches.
  3. To develop recommendations for an inpatient retraining protocol that could then be evaluated in a multi-center trial.
  4. To document the retention of UE and hand improvements after SaeboFlex training is discontinued as well as the carry over of these gains into daily function after therapy has been discontinued.

Condition Intervention
Stroke
Hemiplegia
Device: SaeboFlex Dynamic Hand Orthosis
Procedure: Saebo F.T.M. Arm Training Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Pilot Study Investigating the Feasibility of Using a Functional Tone Management (F.T.M.) Arm Training Program With the SaeboFlex Dynamic Hand Orthosis on an Inpatient Population

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • Hand grip strength (measured using dynamometry) [ Time Frame: At admission and at discharge ]

Secondary Outcome Measures:
  • Length of Stay (days) [ Time Frame: The duration of the subject's inpatient hospital stay. ]
  • Stroke Impact Scale Score [ Time Frame: At admission and at discharge ]
  • Action Research Arm Test Score [ Time Frame: At admission and at discharge ]
  • Ashworth Assessment (Upper Extremity) Scores [ Time Frame: At admission and at discharge ]
  • Fugl-Meyer Assessment (Upper Extremity) Scores [ Time Frame: At admission and at discharge ]
  • Goniometric Range of Motion Evaluation, Passive and Active (Shoulder, Elbow, and Wrist) [ Time Frame: At admission and at discharge ]
  • Assessment of Active Range of Motion (Fingers, as ¼ range, ½ range, ¾ range or full range) [ Time Frame: At admission and at discharge ]

Enrollment: 24
Study Start Date: August 2005
Study Completion Date: May 2006
Detailed Description:

Therapeutic interventions for the recovery of hand function after a neurological injury have historically been very limited. A significant body of research now supports the use of an upper extremity retraining approach for functional recovery after neurological injury. Few therapeutic approaches offer any intervention specifically focused on grasp and release retraining. In an effort to address this deficit, the SaeboFlex dynamic hand orthosis was developed by occupational therapists. The F.T.M. Arm Training Program has been safely used by hundreds of occupational and physical therapists on over one thousand patients in outpatient neurological rehabilitation over the past two years. It is currently an accepted modality of treatment for the management of hand paresis in the acquired brain injury population. During that time, two factors, other than the severity of the initial injury, were identified as having a significant affect on the outcomes achieved in treatment. They are learned non-use and soft tissue shortening of the finger flexors. All treatment delivered to the subjects that partake in this study will be clinical care and the only research component of this study will be the assessment of outcomes. The purpose of this study is to explore the proper treatment dosage and treatment protocol for the application of the F.T.M. Program to the inpatient post stroke rehabilitation population. Additionally, information on functional outcome measures will be collected and compared to a matched control group that undergoes the standard therapeutic protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older,
  • Must be seen within three full working days of admission for screening
  • Alert and Oriented to person and place with the ability to complete at a minimum a one step verbal command,
  • Demonstrated active range of motion of 10 degrees shoulder flexion / abduction and 10 degrees of elbow flexion / extension
  • 1/4 range of volitional finger flexion when the affected hand is passively positioned in a minimum of 15degrees of wrist extension with the MCP’s at neutral and PIP’s / DIP’s in extension
  • Patient must be independent with seated posture in a chair with a firm seat and back support but no arm rests
  • Patient can maintain independent seated balance when unaffected upper extremity is fully outstretched in any direction
  • Admitted to inpatient stroke rehabilitation at Kessler Institute

Exclusion Criteria:

  • Inpatient physician unwilling to clear patient to participate
  • Medically unsuitable for therapeutic intervention,
  • Using the affected hand and arm, able to volitionally grasp and release a racquet ball x10 at maximal volitional shoulder flexion with wrist extension of 10 degrees or more.
  • Flaccidity in the affected UE or hand
  • Fixed joint deformities, contractures or joint hypermobility that prevents proper joint positioning in the orthosis.
  • Hx of rheumatoid arthritis, carpal tunnel syndrome or other hand neuropathy
  • Moderate to severe weeping or pitting edema
  • No previous stroke prior to the one prompting admission
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489580

Locations
United States, New Jersey
Kessler Institute for Rehabilitation
East Orange, New Jersey, United States, 07018
Sponsors and Collaborators
Kessler Foundation
Saebo, Inc.
Investigators
Principal Investigator: Elie P Elovic, M.D. Kessler Medical Rehabilitation Research & Education Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00489580     History of Changes
Other Study ID Numbers: E-519-05
Study First Received: June 20, 2007
Last Updated: July 23, 2007
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Kessler Foundation:
stroke
weakness
motor recovery

Additional relevant MeSH terms:
Hemiplegia
Stroke
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 20, 2014